This job is currently Archived,
Senior Manager/ Associate Director, Argus Database Administrator San Diego United States,
Posted on : 21 March 2017
Execute and/or oversee all functions of Drug Safety Systems in meeting Drug Safety and Pharmacovigilance departmental objectives for overall compliance as outlined by the VP, Drug Safety. Management of Direct Reports as may be required.
- Lead the design, implementation and support of applications in support of Drug Safety objectives, including Argus Safety, MedDRA, etc.
- Database administrator in charge of quality review of all product configuration changes to Argus
- Lead the implementation of standard and ad hoc reporting process
- Oversee programming, validation, and generation of reports for data analysis, including periodic reports and ICH PSUR line listings
- Interpret regulatory changes as they impact technology and provide technology expertise to implement regulatory changes for maintaining compliance.
- Update and review training documentation for Drug Safety SOPs related to Argus database and data management
- Plan and implement MedDRA version management and upgrades as required by the Director of Drug Safety and Pharmacovigilance Department.
- Manage and compile key drug safety case processing and resource requirement metrics
- Act as primary liaison with IT to support delivery of computing infrastructure
- Ensure compliance with relevant policies and procedures
- Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies
- Drive resolution of complex, cross-functional issues
- MS in technical field preferred; or Bachelor s Degree with requisite experience
- Minimum 8 years of experience within pharmaceutical industry required, including 4 years of experience with drug safety systems and applications
- Minimum 3 years of Drug Safety experience
- Minimum 1 years of management experience required
- Prior and recent post marketing experience in safety management and safety reporting at pharmaceutical sponsor-applicant company, is preferred.
REQUIRED KNOWLEDGE AND ABILITIES:
- Advanced understanding of FDA, EU regulations supporting the submission of adverse events for post-marketing and investigative drugs
- Advanced understanding of ICH guidelines-Basic understanding of MedDRA structure
- Working knowledge of Oracle databases and PLSQL programming
- Advanced understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements
- Advanced skills in report generation using Business Objects or equivalent
- Advanced understanding of Drug Safety Systems (Argus Safety Database preferred)
- Proficiency with basic MS Office applications
- Working knowledge of scientific terms and medical terminology
- Solid written, verbal communication, and interpersonal skills
- Time management and ability to prioritize workload (self, others)
- Quality orientation: attention to detail, accuracy
- Advanced understanding of safety processes
- Understanding of training concepts
- Solid project management skills
- Basic understanding of documentation requirements in a regulated environment
- Basic knowledge of regulatory dossier and controlled document application
San Diego CA United States
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